SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problem
Electrical Shorting (2926)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/1901 |
Event Type
malfunction
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Event Description
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It was reported that the motor drive unit is not working because the cable shorted.Since further information is not available, it is unknown if the allegation happened during surgery or not.Injuries were not indicated.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of shorting out could not be reproduced.Product did fail for handpiece sensor fault but passed high speed testing (100-10,000 rpms) for 5 minutes each in forward, reverse and oscillate directions.No shorts were detected in cable assembly.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.
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Search Alerts/Recalls
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